Medical Device Recalls
This is our largest category by volume. The FDA tracks recalls for an enormous range of medical devices: implants, pacemakers, insulin pumps, surgical tools, blood glucose monitors, X-ray machines, prosthetics, contact lenses, and home health equipment, among many others. We have records dating back to 2005 and add new ones as the FDA publishes them.
Device recalls can happen because of software bugs, manufacturing defects, bacterial contamination, incorrect labeling, or design flaws that lead to inaccurate results or equipment failure. Class I recalls are the most serious and mean the device could cause injury or death.
Showing 2781–2800 of 38,428 recalls
Recalled Item: CardiFocus Heartlight X3 Catheter- Intended in the treatment of atrial
The Issue: Damage to the sterile barrier pouch of catheter,
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Vista Brite Tip
The Issue: Catheter manufactured at the incorrect length
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DR DIULUS INJECTION PACK
The Issue: ACS is unable to confirm product sterilization assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LABOR & DELIVERY PPS
The Issue: ACS is unable to confirm product sterilization assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: Medline ReNewal Reprocessed Livewire Steerable Electrophysiology Catheters
The Issue: Devices may have higher than expected amounts of
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: MAJOR VASCULAR PACK
The Issue: ACS is unable to confirm product sterilization assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LABOR & DELIVERY PACK
The Issue: ACS is unable to confirm product sterilization assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CENTRAL LINE PICC
The Issue: ACS is unable to confirm product sterilization assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DIAGNOSTIC NEURO IR TRAY
The Issue: ACS is unable to confirm product sterilization assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: GENERAL LAPAROSCOPIC PACK-LF
The Issue: ACS is unable to confirm product sterilization assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: C-SECTION PACK
The Issue: ACS is unable to confirm product sterilization assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: DELIVERY PACK
The Issue: ACS is unable to confirm product sterilization assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: OPEN HEART ADULT - SIDE A
The Issue: ACS is unable to confirm product sterilization assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: HIP SCOPE
The Issue: ACS is unable to confirm product sterilization assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LACERATION TRAY
The Issue: ACS is unable to confirm product sterilization assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LAPAROSCOPY PACK
The Issue: ACS is unable to confirm product sterilization assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CYSTO
The Issue: ACS is unable to confirm product sterilization assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: LACERATION TRAY
The Issue: ACS is unable to confirm product sterilization assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: VEIN TRAY
The Issue: ACS is unable to confirm product sterilization assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.
Recalled Item: CYSTO PACK
The Issue: ACS is unable to confirm product sterilization assurance
Recommended Action: Stop using. Contact the manufacturer or your healthcare provider.